Agendia to Showcase New Research on AI-Driven Digital Pathology at ESMO 2026

Agendia, Inc., a leader in precision oncology for breast cancer, announced today that it will present new research during a podium presentation on the development of an artificial intelligence (AI)-driven digital pathology approach for MammaPrint^Ⓡ at the European Society for Medical Oncology (ESMO) Congress 2026, which takes place October 23 to 27, 2026, in Madrid. The company will also present two additional posters at ESMO.

AI-driven digital pathology approaches are rapidly developing to expand access to genomic testing globally. Agendia’s first presentation, submitted as a late-breaking abstract, focuses on the development and validation of an AI-driven MammaPrint approach based on the analysis of routine whole slide images of breast cancer tissue.

The following are details of the late-breaking abstract to be presented on the podium:

PODIUM PRESENTATION: AI Driven Digital Pathology for the 70 Gene Recurrence Signature: Development and Validation in Early Stage Breast Cancer

• Presenter: Laura van ‘t Veer, PhD, Co-founder and Chief Research Officer, Agendia
• Session: AI and digital health
• Abstract Number: LBA20
• Date / Time: Saturday, October 24, 2026 | 14:45 to 16:15 CEST
• Location: Bilbao Auditorium, Hall 3

Agendia will also present two additional posters that draw on the ongoing real-world FLEX Study, demonstrating how a large, real-world breast cancer research platform can support investigations across biomarkers, inherited mutations and genomic tumor biology. The research will highlight the relationship between genomic risk and Ki67 and the correlation between germline BRCA1 and BRCA2 mutations with gene expression profiling.

“Germline BRCA1 and BRCA2 mutations are associated with distinct breast cancer phenotypes, but their association with gene expression-based subtypes has not been well-studied. Ki67 is a biomarker whose utility is limited by variability between laboratories and by the lack of consensus on meaningful levels of expression," said William Audeh, M.D., M.S., Chief Medical Officer at Agendia. "Both studies we are bringing to ESMO 2026 to illustrate how genomic risk classification correlates with these biomarkers in a real-world population. The FLEX Study has allowed questions like these to be answerable through the analysis of large scale real-world evidence, and we look forward to sharing the complete findings in Madrid following their scheduled presentations.”

The following are details of the two additional abstracts that have been accepted as poster presentations:

• 70-Gene Signature Provides Prognostic Value Beyond Ki67 in HR+HER2- Early Breast Cancer (EBC)
  • Presenter: Michael Gnant, MD, Full Professor of Surgery, Medical University of Vienna
  • Session: Breast cancer, early stage
  • Presentation Number: 578P
  • Date / Time: Saturday, October 24, 2026 | 12:00 to 12:45 CEST

• Impact of Germline BRCA1 and BRCA2 Mutations on 70-Gene Signature Risk for Patients Enrolled in the FLEX Study
  • Presenter: Amir Sonnenblick, MD, PhD, Associate Professor, Tel Aviv University
  • Session: Breast cancer, early stage
  • Abstract Number: 564P
  • Date / Time: Saturday, October 24, 2026 | 12:00 to 12:45 CEST

About the FLEX Study
The MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles (FLEX) Study (NCT03053193) is a large-scale, prospective, observational breast cancer study that links whole transcriptome profiling, including MammaPrint® and BluePrint®, with complete clinical data. The largest and most diverse early-stage breast cancer cohort, the FLEX Study has enrolled over 25,000 patients globally, including 2,235 self-reported Black/African American, 2,125 Latin American/Hispanic, and 602 Asian American/Pacific Islander patients. FLEX also represents one of the largest cohorts of invasive lobular carcinoma (ILC), with 2,981 ILC and 853 mixed ILC/ductal histology tumors. FLEX supports collaborative substudies designed to expand our understanding of breast cancer biology and inform more personalized, equitable care.

About Agendia
Agendia is a global leader in precision oncology focused on early-stage breast cancer. The company’s genomic assays, MammaPrint + BluePrint, deliver essential biological insights to inform personalized treatment decisions for patients and their care teams. With operations in Amsterdam and Irvine, Agendia partners with academic and community oncology centers worldwide to generate real-world evidence through the landmark FLEX Study (NCT03053193), the largest whole-transcriptome registry of early-stage breast cancer.

About MammaPrint
MammaPrint is the only FDA-cleared gene expression profiling test that assesses a woman’s risk of distant metastasis in early-stage breast cancer. By analyzing 70 key genes in a tumor, it stratifies risk into four categories — UltraLow Risk, Low Risk, High Risk 1, and High Risk 2 — to help guide treatment planning, including chemotherapy benefits and de-escalation Decisions.

About BluePrint
BluePrint is an 80-gene molecular subtyping assay that reveals the functional biology driving tumor growth, classifying tumors as Luminal-type, HER2-type, or Basal-type. By defining intrinsic subtypes beyond traditional immunohistochemistry, BluePrint provides critical insights to optimize treatment selection and improve outcomes.

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